A Delhi High Court has declined Novo Nordisk’s bid to halt Reddy’s ongoing production, allowing exports while patent validity proceeds to trial.
The FDA said an ANDA managed to be submitted during a period when no new ANDAs could be accepted.
In the wake of recent FDA guidance setting out a streamlined approach to biosimilar registration, developers have spent the past month responding. While most reactions have been enthusiastic, some firms have sounded a note of caution.
Lupin announced US FDA approval for its Armlupeg (pegfilgrastim-unne) biosimilar and a licensing deal with Valorum in a span of a few days.
EPO Appeal Board overturns earlier ruling and invalidates Biogen’s 480mg Tecfidera patent, clearing the way for broader dimethyl fumarate competition in Europe.
ANDA sponsors received 20 days to pay fees associated with applications submitted during the government shutdown, while NDA and BLA sponsors only received five days.
FDA clears Accord’s first fully in-house biosimilars, with a US launch planned for its denosumab biosimilars in 2026.
Back-to-back FDA nods for generic Restasis and ProAir highlight Amneal’s growing strength in complex sterile and inhalation manufacturing.
The FDA proposed changes to the formal meeting system for sponsors in the next generic drug user fee program cycle, in part to speed timelines.
Hot on the heels of denosumab launches by four suppliers on the first day of December, more biosimilar challengers are piling into the European market with their own rivals to Prolia and Xgeva. And the space is only going to get more crowded as further versions launch.
Korean firm’s Eydenzelt biosimilar win full label alignment with Eylea, including all approved ophthalmic indications.
In an exclusive interview, Generics Bulletin spoke to a trio of experts who argue that biosimilar cell and gene therapies are technically within reach but demand unprecedented regulatory clarity, manufacturing evolution and economic alignment before they become reality.
The European Commission says it will soon publish an updated study on the impact of the Urban Waste Water Treatment Directive on the pharmaceutical and cosmetics industry and that it would support member states in avoiding “unintended consequences.”
Four companies have confirmed launches of denosumab biosimilars in Europe, setting the stage for a competitive market for Prolia and Xgeva biosimilars.
Zydus inks a new 505(b)(2) oncology deal, taking over the commercialization of RK Pharma’s undisclosed sterile injectable in the US.
In announcement of approving VKT Pharma’s application, FDA included storage and handling instructions common in labeling, suggesting concerns persist about the potential for NDMA to form after products are distributed.
After the recent onset of European biosimilar competition to aflibercept, the next big biologic LOE on the horizon in Europe is denosumab. Several more approvals have just arrived for rivals to Prolia and Xgeva, setting up a fiercely competitive market once biosimilars launch imminently.
Aeon’s cash infusion and upcoming FDA session, now rescheduled for early next year, positions firm to push ABP-450 biosimilar closer to market entry.
A webpage for PharmaTher’s ketamine product lacked risk information and made misleading claims about the approved indication, the FDA said in a rare ad/promo violation letter to an ANDA holder.
As Alvotech continues to reorganize its senior team with the promotion of chief scientific officer Joseph McClellan to chief operating officer, multiple other firms – including Hikma, Hyloris, CNX and Cingulate – have also announced executive updates.